510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 1243 of 3531

510(k) clearances, page 1243 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K060651	Proxis System, Model Eps101	Abbott Medical	NFA	Class II	2006-09-13
K052536	Algicell Ag	Derma Sciences Canada, Inc.	FRO	Unclassified	2006-09-13
K062509	Incoris Zi	Sirona Dental Systems GmbH	EIH	Class II	2006-09-12
K062427	Verte-Stack Spinal System	Medtronic Sofamor Danek	MQP	Class II	2006-09-12
K062408	Smith & Nephew Modular Femoral (Hemi) Head	Smith & Nephew, Inc.	KWL	Class II	2006-09-12
K062160	Go Go Mini, Model Sc30	Pride Mobility Products Corp	INI	Class II	2006-09-12
K061668	Optecure +Ccc	Exactech, Inc.	MBP	Class II	2006-09-12
K052206	Zeus Male Condom Applicator	Condax, LLC	HIS	Class II	2006-09-12
K062239	Glucose Hk New Formulation Test System	Roche Diagnostics GmbH	CFR	Class II	2006-09-11
K062234	Modification to Diadexus Plac Test	Diadexus, Inc.	NOE	Class II	2006-09-11
K062229	Ctc Workstation, Model 2200	Medical Diagnostic Technologies, Inc.	LLZ	Class II	2006-09-11
K062196	Sfx Snap-Fit Cross Connector	DePuy Spine, Inc.	MNH	Class II	2006-09-11
K062062	Voyager Pacs System	Voyager Imaging	LLZ	Class II	2006-09-11
K062058	Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080	Medrad, Inc.	NBW	Class II	2006-09-11
K062039	Biopsy Digit-Am	Giotto USA, LLC	IZH	Class II	2006-09-11
K062022	Haemophilus/streptococcus Pneumoniae (Hp) Mic Plate	Trek Diagnostic Systems, Ltd.	JWY	Class II	2006-09-11
K061973	Synthes 3.5Mm Spring Plate	Synthes (USA) Products LLC	HRS	Class II	2006-09-11
K061802	Dimension Vista Cardiophase Hscrp Flex Reagent Cartridge, Protein 2 Calibrator, Hscrp Control Low, Hscrp 1 Control High	Siemens Healthcare Diagnostics Inc.	NQD	Class II	2006-09-11
K061795	Dimension Vista Pbnp Flex Reagent Cartridge and Calibrator	Siemens Healthcare Diagnostics Inc.	NBC	Class II	2006-09-11
K061648	Depuy Graduated Compartmental Knee (Gck)	Depuy Orthopaedics Inc.	NPJ	Class II	2006-09-11
K061611	Bosworth Dentin Resin	Harry J. Bosworth Co.	KLE	Class II	2006-09-11
K061515	Renalsoft	Baxter Healthcare Corporation	KPF	Class II	2006-09-11
K061471	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Bp3mc1-Pc	Microlife Intellectual Property GmbH	DXN	Class II	2006-09-11
K061432	Hospira Enteral Feeding Set, Model 20640	Abbott Medical	KNT	Class II	2006-09-11
K060329	Endofast Reliant System	Endogun Medical Systems	FTL	Class II	2006-09-11
K062522	Powder-Free Vinyl Patient Examination Gloves	Jiangsu Jaysun Glove Co., Ltd.	LYZ	Class I	2006-09-08
K062506	Incoris Al	Sirona Dental Systems GmbH	EIH	Class II	2006-09-08
K062483	Mini Power Chair, Model Mn 5000	Line Ind.(Shanghai) Co., Ltd.	ITI	Class II	2006-09-08
K062420	5F Sherpa Active Nx Guide Catheter	Medtronic, Inc.	DQY	Class II	2006-09-08
K062404	Transear Bone Conduction Hearing Aid	Ear Technology Corporation	LXB	Class II	2006-09-08
K062348	Timesh Self Drilling Screw	Medtronic Neurosurgery	HWC	Class II	2006-09-08
K062315	Superdimension/bronchus Premium 2	Medtronic, Inc.	JAK	Class II	2006-09-08
K062291	Vpap Malibu with H2i	ResMed Corp	BZD	Class II	2006-09-08
K062206	Bd Phoenix Automated Microbiology System - Moxifloxacin (Strep) 0.0625 - 8Ug/ml	Becton Dickinson & Co	LON	Class II	2006-09-08
K061940	Synthes Lcp Ankle Arthrodesis Plates	Synthes (USA) Products LLC	HRS	Class II	2006-09-08
K061835	Stryker Silverglide Bipolar Forceps Reusable Cable; Disposable Cable	Stryker Corp.	GEI	Class II	2006-09-08
K061735	Infibra, Model 1200	Global Dental Products, Inc.	EBI	Class II	2006-09-08
K061717	Zimmer One-Piece Implant, 3.7 Mm, Angled	ZimVie US Corp LLC	DZE	Class II	2006-09-08
K061688	Anti-Snoring / Sleep Apnea Device	Tomed Dr. Toussaint GmbH	LRK	Class II	2006-09-08
K061664	Formcore Dc, Model 28-700100	J. Morita USA, Inc.	EBF	Class II	2006-09-08
K061591	Modification to Cd Horizon Spinal System	Medtronic Sofamor Danek	KWP	Class II	2006-09-08
K061410	Screw-Vent Implant System, Sv;tapered Screw -Vent Implant System, Tsv;advent Implant System,av;zimmer One-Piece Implant	ZimVie US Corp LLC	DZE	Class II	2006-09-08
K061008	Quickvue Rsv (20 Test Kit), Model 20193; (2 Test Kit), Model 20199	Ortho-Clinical Diagnostics, Inc.	MCE	Class I	2006-09-08
K060700	Euroimmun Pr3 Elisa Kit. Euroimmun Mpo Elisa Kit.	Euroimmun US Inc.	MOB	Class II	2006-09-08
K060333	Dialysis Services, Inc., Typhoon Bicarb Mixing and Distribution System	Dialysis Services, Inc.	FIN	Class II	2006-09-08
K052968	Modification to: Orlus Mini Screw	Ortholution Co., Ltd.	DZE	Class II	2006-09-08
K062048	Aesthera Photopneumatic (Ppx) System	Aesthera Corporation	GEX	Class II	2006-09-07
K061785	Cyl-Fil Oxygen System	Responsive Respiratory Inc.	CAN	Class I	2006-09-07
K060182	Trumpet Valve Handle with 3-Metre Tubing, Single Spike, 5Mm Cannula, Trumpet Valve Handle with 3-Metre Tubing, Double	Australian Surgical Devices	GCJ	Class II	2006-09-07
K052523	Proxis System	Velocimed, Inc.	NFA	Class II	2006-09-07